510(k) Report

510(k) · Cleared

Cleared

Vitamesh Macroporous PP Surgical Mesh

K060520510(k) AbbreviatedCleared Mar 28, 200629-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Proxy Biomedical, Ltd. · FTL Mesh, Surgical, Polymeric

Cleared on Mar 28, 2006 after a 29-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.

Decided
Mar 28, 2006
Review
29 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
0

14 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2018: 2 descendants cleared2007: 1 descendant cleared2009: 1 descendant cleared2008: 1 descendant cleared2010: 2 descendants cleared2020: 1 descendant cleared2015: 1 descendant cleared2012: 1 descendant cleared2017: 1 descendant cleared2013: 1 descendant cleared20052010201520202025
  1. This deviceK060520 Vitamesh Macroporous PP Surgical MeshProxy Biomedical, Ltd. · 2006
  2. Descendant · cites it directly · 10 of its ownK063671 Rebound HRDMinnesota Medical Development, Inc. · 2007
  3. Descendant · 2 generations on · 7 of its ownK092726 Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010
  4. Descendant · 3 generations on · 6 of its ownK102766 Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · Recalled
  5. Descendant · 4 generations on · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
  6. Descendant · 4 generations on · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 12010: 22011: 22012: 12013: 12015: 12017: 12018: 22020: 1
2007high 2 (2010) · low 0 (2014)2026

Most influential descendants

Showing 5 of 14 · See all
  • K063671Rebound HRDMinnesota Medical Development, Inc. · 2007 · cites it directly10descendants
  • K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010 · 2 generations on7descendants
  • K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · 3 generations on6descendants
  • K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · 4 generations on5descendants
  • K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060520Vitamesh Macroporous PP Surgical MeshProxy Biomedical, Ltd.2006—
+1K063671Rebound HRDMinnesota Medical Development, Inc.2007—
+2K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd.2010—
+3K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc.20102
+4K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc.2011—
+4K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with…C.R. Bard, Inc.201215

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200910
201020
201120
201210
201310
201510
201710
201820
202010
FIG. 1 — Lineage of K060520, 2006–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FTL device

  1. #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Bard PTFE Mesh (Davol Inc.)
Named without a submission number
—
*—Mersilene Mesh (Ethicon, Inc.)
Named without a submission number
—
*—Bard Mesh (C.R. Bard, Inc.)
Named without a submission number
—

What descends from it? (14)

See all 14

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063671Rebound HRDMinnesota Medical Development, Inc.200710
K172636VitaMESH Macroporous PP Surgical MeshProxy Biomedical, Ltd.20181
K111121Vitamesh (TM) Blue Lightweight Macroporous PP Surgical MeshProxy Biomedical, Ltd.20110

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K063671 (Minnesota Medical Development, Inc., 2007) has gone furthest, with 10 descendants of its own.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTL

6in 2025

2007: 202008: 232009: 152010: 182011: 152012: 122013: 82014: 112015: 122016: 32017: 62018: 122019: 42020: 52021: 22022: 62023: 42024: 22025: 62026 (partial year): 2
2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007: 92 days median2008: 114 days median2009: 97 days median2010: 132 days median2011: 90 days median2012: 213 days median2013: 90 days median2014: 70 days median2015: 121 days median2016: 186 days median2017: 132 days median2018: 105 days median2019: 99 days median2020: 138 days median2022: 195 days median2023: 29 days median2025: 30 days median
2007high 213 (2012) · low 29 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTL

1in 2020

2007: 22008: 12009: 12010: 122011: 82012: 22013: 12014: 32017: 12018: 12020: 1
2007high 12 (2010) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTL

3,487in 2025

2007: 1,7372008: 1,5692009: 1,9062010: 2,1752011: 3,6082012: 14,7002013: 26,5192014: 2,6832015: 2,5262016: 2,4172017: 3,9472018: 11,8932019: 21,7242020: 18,8192021: 16,2842022: 11,4392023: 8,0252024: 8,5652025: 3,487
2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007209221,737
20082311411,569
2009159711,906
201018132122,175
2011159083,608
201212213214,700
2013890126,519
2014117032,683
20151212102,526
2016318602,417
2017613213,947
201812105111,893
2019499021,724
20205138118,819
20212—016,284
20226195011,439
202342908,025
20242—08,565
202563003,487
20262—0—

What is it indicated for?

Proxy Biomedical VITAMESHTM surgical mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

Indications for use as stated in the FDA summary.

More from Proxy Biomedical, Ltd.

6 FDA decisions under this applicant name. See the company

  • K172636VitaMESH Macroporous PP Surgical MeshProxy Biomedical, Ltd. · 2018
  • K111121Vitamesh (TM) Blue Lightweight Macroporous PP Surgical MeshProxy Biomedical, Ltd. · 2011
  • K052100Modification to Motifmesh Soft Tissue PatchProxy Biomedical, Ltd. · 2005
  • K051245Polyform Synthetic MeshProxy Biomedical, Ltd. · 2005
  • K050678Motifmesh Soft Tissue PatchProxy Biomedical, Ltd. · 2005

Recent decisions in FTL

The FTL category page

  • K260474Liora Monofilament ScaffoldTELA Bio, Inc. · 2026
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
  • K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025

https://510kreport.com/device/K060520 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060520: Vitamesh Macroporous PP Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060520

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026